HRAM multi-attribute method for critical quality attribute monitoring and new peak detection

contributed by Thermo Fisher Scientific | 10/01/2019

Goal

The aim of this work is to develop a high-resolution accurate mass (HRAM) multi-attribute method (MAM) for the analysis of monoclonal antibody (mAb) critical quality attributes (CQAs). In this application note, we will describe the optimization and application of the Thermo Scientific™ HR Multi-Attribute Method as a complete workflow to monitor CQAs of the NISTmAb standard, including glycosylation, deamidation, isomerization, succinimide formation, oxidation, C-terminal lysine truncation, N-terminal pyroglutamate, and glycation, under normal and stressed conditions. In addition, we will demonstrate the capability of the HR MAM workflow for new peak detection (NPD) using spiked and stressed samples. The importance of HRAM in CQA quantitation and NPD will be discussed.

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